The U.S. Food and Drug administration granted regular approval to pertuzumab (Perjeta; Genentech) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Read full press release.

The U.S. Food and Drug Administration granted regular approval to obinutuzumab (Gazyva; Genentech) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II buly; III, or IV follicular lymphoma (FL). Read full press release.

The U.S. Food and Drug Administration approved emicizumab-kxwh (Hemlibra; Genentech) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congential factor VIII deficiency) with factor VIII inhibitors. Read full press release. 

The U.S. Food and Drug Administration granted regular approval to brentuximab vedotin (Adcetris; Seattle Genomics) for the treatment of adult-patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systematic therapy. Read full press release. 

The U.S. Food and Drug Administration granted regular approval to dasatinib (Sprycel; Bristol-Myers Squibb) for the treatment of pediatric patients with Philadelphia chromosome-positive (PH+) chronic myeloid leukemia (CML) in the chronic phase. Read full press release.

The U.S. Food and Drug Administration granted regular approval to alectinib (Alecensa; Genentech) for the treatment of partients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Read full press release. 

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb, Amgen) as a biosimilar to Avastin (bevacizumab, Genentech). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum- containing chemotherapy and, if appropriate, HER2/neu- targeted therapy. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo; Bristo-Myers Squibb) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib; Bayer) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments know as systemtic therapies. Read full press release.